The following data is part of a premarket notification filed by Elastomade Accessories Sdn Bhd with the FDA for Royal Shield Rubber Dams.
| Device ID | K942992 |
| 510k Number | K942992 |
| Device Name: | ROYAL SHIELD RUBBER DAMS |
| Classification | Dam, Rubber |
| Applicant | ELASTOMADE ACCESSORIES SDN BHD 89 2ND FLOOR, JALAN SS 15/4C SUBANG JAYA Petaling Jaya, MY 47500 |
| Contact | Katherine Ooi |
| Correspondent | Katherine Ooi ELASTOMADE ACCESSORIES SDN BHD 89 2ND FLOOR, JALAN SS 15/4C SUBANG JAYA Petaling Jaya, MY 47500 |
| Product Code | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-20 |
| Decision Date | 1994-09-21 |